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Product NDC Code | 68599-5207 | ||||
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Drug Name | Hand sanitizer |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LOTION | ||||
RxCUI drug identifier | 1809903 | ||||
Application Number | 505G(a)(3) | ||||
Labeler Name | McKesson Medical-Surgical | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Ethanol 70%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Wet hands thoroughly with product. Allow to dry without wiping. Use no water or towels
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aloe Barbadensis Leaf Juice, Ammonium Acryloyldimethyltaurate/VP Copolymer, Butylene Glycol, Calcium Pantothenate (Vitamin B5), Cetyl Alcohol, Fragrance, Glycerin, Glyceryl Laurate, Hydroxypropyl Cellulose, Isopropyl Myristate, Maltodextrin, Niacinamide (Vitamin B3), Pyridoxine HCl (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C),Sodium Starch Octenylsuccinate, Titanium Dioxide, Tocopherol (Vitamin E), Tocopheryl Acetate (Vitamin E), Trehalose, Water
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses An effective antimicrobial hand cleanser for topical application Recommended for repeated use Reduces transient microorganisms on intact skin Keeps hands from drying out due to repeated uses
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.Hand Sanitizer Lotionized Hand Sanitizer GLYCERYL LAURATE ALCOHOL ALCOHOL OCTENYLSUCCINIC ACID WATER SODIUM ASCORBYL PHOSPHATE TITANIUM DIOXIDE TOCOPHEROL BUTYLENE GLYCOL AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER PYRIDOXINE HYDROCHLORIDE MALTODEXTRIN ALOE VERA LEAF TREHALOSE HYDROXYPROPYL CELLULOSE, UNSPECIFIED ISOPROPYL MYRISTATE GLYCERIN NIACINAMIDE CETYL ALCOHOL SILICON DIOXIDE .ALPHA.-TOCOPHEROL ACETATE CALCIUM PANTOTHENATE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.68599-5207-1 Thera Lotionized Hand Sanitizer An antiseptic hand sanitizer with moisturizers and emollients to help prevent drying of the skin. NET CONTENTS 8 fl oz (237 mL) MFR # 53-LHS8 each
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Not tested on animals
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-800-777-4908
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.When using this product: Avoid contact with eyes In case of eye contact, flush with water for 15 minutes Discontinue use and see a doctor if irritation occurs Avoid contact with broken skin
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For External Use Only Flammable, keep away from fire or open flame
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API